1. Field
Aspects of the present invention relate to a radionuclide generator having a column assembly that may be terminally sterilized without the introduction of excess moisture.
2. Discussion of Related Art
Radionuclide generators include a column that has media for retaining a long-lived parent radionuclide that spontaneously decays into a daughter radionuclide that has a relatively short-lived life. The column may be incorporated into a column assembly that has a needle-like outlet port that receives an evacuated vial to draw saline or other eluant liquid, provided to a needle-like inlet port, through a flow path of the column assembly, including the column itself. This liquid may elute and deliver daughter radionuclide from the column and to the evacuated vial for subsequent use in nuclear medical imaging applications, among other uses. One example of a generator is shown and described in U.S. Pat. No. 5,109,160, owned by Lantheus Medical Imaging, Inc., and which is incorporated by reference herein in its entirety.
Sterilization to some degree is generally performed on radionuclide generators that are used in the medical industry. Sterilization may be performed by exposing a column assembly of a radionuclide generator, having a column loaded with parent radionuclide, to a saturated steam environment. During this process, liquid that resides in the column assembly, including the column and tubes that extend between the column and the inlet and outlet ports may be heated to vapor form (e.g., steam) to kill and/or inactivate contaminants. A vent may be included at the outlet port to allow both the introduction of steam and the release of vapors from the column during the sterilization process.
As discussed in U.S. Pat. No. 5,109,160, it may be desirable to provide a radionuclide generator as a terminally sterile product—that is, a product that is sterilized in its final container, or at least that is sterilized with the flow path between the inlet port, the column, and the outlet port assembled in its final form, including any vented or non-vented vented caps over the inlet and outlet ports. This may be contrasted with aseptic sterilization where at least some of the individual components that make up the flow path between the inlet port, the column, and the outlet port are sterilized separately and subsequently assembled together.